Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae After Traumatic Brain Injury
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Adverse events and serious adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in the management of neurological sequelae after traumatic brain injury
详细描述
To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in 25 patients with neurological sequelae after traumatic brain injury compared with 25 patients in control group (no intervention) at the time points of baseline, 3rd month (D90), 6th month (D180), and 12th month (D360).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: from 20 to 50 years
- •Gender: either sex
- •Duration after Brain trauma: 6 - 12 months
- •Functional Independence Measure - FIM < 69
- •Closed head injury
排除标准
- •Neurologic impairment or neurological disease before the time of the accident.
- •Active infections
- •Tumours or failure of heart, lung, liver or kidney, respiratory distress syndrome
- •Anaemia, clotting disorder
- •Pregnancy
- •Alcoholic
- •Patient was unemployed or did not attend school before the accident.
- •Severe injuries: spinal cord injury, pelvic inflammation, cardiopulmonary
研究组 & 干预措施
Treatment (BM-MNC trasnplatation)
Autologous bone marrow-derived mononuclear cell will transplant at baseline, and the second transplantation will be performed 6 months after the first transplantation and combination with rehabilitation therapy
干预措施: autologous bone marrow-derived mononuclear cell transplantation (Biological)
Treatment (BM-MNC trasnplatation)
Autologous bone marrow-derived mononuclear cell will transplant at baseline, and the second transplantation will be performed 6 months after the first transplantation and combination with rehabilitation therapy
干预措施: Rehabilitation therapy (Other)
Control group
rehabilitation therapy
干预措施: Rehabilitation therapy (Other)
结局指标
主要结局
Adverse events and serious adverse events
时间窗: up to the 12-month period following treatment
Incidence of the adverse events or serious adverse events after transplantation
Functional Independence Measure
时间窗: up to the 12-month period following treatment
Functional Independence Measure assess and grade the functional status of patient
Extended Glasgow Outcome Scale
时间窗: up to the 12-month period following treatment
Extended Glasgow Outcome Scale classifies global outcome in TBI survivors
次要结局
- to monitor the functional metabolic changes in the brain of the patients(up to the 12 months after transplantation)
- Short Form 36(up to the 12-month period following treatment)